Safety and Efficacy of Inhaled Treprostinil in Patients With PAH (INTREPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01557647
Recruitment Status : Withdrawn
First Posted : March 19, 2012
Last Update Posted : March 26, 2012
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Inhaled treprostinil Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil.
Study Start Date : June 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: inhaled treprostinil Drug: Inhaled treprostinil
0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.

Placebo Comparator: placebo Drug: Placebo
placebo inhalation solution

Primary Outcome Measures :
  1. Six-minute walk test [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Time to clinical worsening [ Time Frame: 1 day to 2.5 years. ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Eligible subjects must:

  • Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed),
  • Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use.
  • Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening.
  • Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.

Responsible Party: United Therapeutics Identifier: NCT01557647     History of Changes
Other Study ID Numbers: RIN-PH-302
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents